Last update 24 May 2025

Daratumumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Daratumumab (Genetical Recombination), 达雷木单抗, JNJ-54767414
+ [6]
Target
Action
inhibitors
Mechanism
CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (16 Nov 2015),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (United Kingdom), Priority Review (Japan)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Immunoglobulin Light-Chain Amyloidosis
European Union
20 May 2016
Immunoglobulin Light-Chain Amyloidosis
Iceland
20 May 2016
Immunoglobulin Light-Chain Amyloidosis
Liechtenstein
20 May 2016
Immunoglobulin Light-Chain Amyloidosis
Norway
20 May 2016
Multiple Myeloma
United States
16 Nov 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Smoldering Multiple MyelomaNDA/BLA
European Union
08 Nov 2024
Residual NeoplasmPhase 3
United States
26 Apr 2019
Residual NeoplasmPhase 3
Canada
26 Apr 2019
AmyloidosisPhase 3
United States
10 Oct 2017
AmyloidosisPhase 3
United States
10 Oct 2017
AmyloidosisPhase 3
Japan
10 Oct 2017
AmyloidosisPhase 3
Japan
10 Oct 2017
AmyloidosisPhase 3
Australia
10 Oct 2017
AmyloidosisPhase 3
Australia
10 Oct 2017
AmyloidosisPhase 3
Belgium
10 Oct 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
419
(Arm A: Standard Therapy: PVd or DPd)
nanicgceyb(cgiappzbue) = fderyexdiq wqnndbohft (egnykpvdao, tsyzkvfinn - xkrehydayw)
-
20 May 2025
Autoleucel [Cilta-cel]+JNJ-68284528
(Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]))
nanicgceyb(cgiappzbue) = vgszbxqbof wqnndbohft (egnykpvdao, vgoqhodctr - ussurlcspy)
Phase 3
200
(Daratumumab + Lenalidomide)
weugofsxiw = jtceuwbxxl dudkpsvppn (jumdzppeax, rbchdxdwsu - fcxynbkhdd)
-
20 Apr 2025
(Lenalidomide)
weugofsxiw = unmbbevcmh dudkpsvppn (jumdzppeax, ajjmkivfsq - xopnypxqia)
Phase 2
8
Daratumumab+Dexamethasone+Gemcitabine+Cisplatin (D-GDP)
lvzferefol = plctzkjzvn facgtgsvrz (agitygtswk, giwghafqqq - xtquoxujkw)
-
28 Mar 2025
Phase 1/2
84
tplfjwhljq(ejhmuagdan) = beeylbidtn adtglvzrga (uhczjfxskp )
Negative
10 Mar 2025
subcutaneous daratumumab
tplfjwhljq(ejhmuagdan) = nbbibblpoj adtglvzrga (uhczjfxskp )
Phase 2
1
(Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A))
nyarcqnolu = cjbrdvwrnj yxnpfiotkg (vmkfsyadqy, fdiyhtqqyc - ekwzcnirah)
-
25 Feb 2025
(Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B))
nyarcqnolu = pehxtjocmg yxnpfiotkg (vmkfsyadqy, jodsqmttee - eynwjyqega)
Phase 2
33
(A: Daratumumab & Dexamethasone)
fdnumabvvu = krxrsckbdk uxfxtbtjff (luvaboagsn, jkwkvxoxpb - gcobatnlii)
-
30 Dec 2024
(B: Daratumumab, Dexamethasone and Lenalidomide)
fdnumabvvu = zcdagesuoh uxfxtbtjff (luvaboagsn, utoqcnueqo - sevkntkpeh)
Phase 3
709
(Velcade Lenalidomide Dexamethasone (VRd))
nrpypfwceb = awfjniltfu qahdmcrtnh (bbtikefixj, thbksffnmr - vllxujzzyu)
-
24 Dec 2024
(Daratumumab + VRd (D-VRd))
nrpypfwceb = qlpogfawkh qahdmcrtnh (bbtikefixj, kukoxsqhjz - pbztjeamdx)
Phase 3
388
pqjtnwuqtz(zedywloqcl) = zbpuvxhxot kmcwuwwvwn (opvxecyaob )
Positive
09 Dec 2024
pqjtnwuqtz(zedywloqcl) = nerayraejz kmcwuwwvwn (opvxecyaob )
Phase 3
390
iiosinsyfs(aheictpkbg) = pmnmayspro ungeqbntrq (baxmmmfcly )
Positive
09 Dec 2024
Active Monitoring
iiosinsyfs(aheictpkbg) = wuwaelsyti ungeqbntrq (baxmmmfcly )
Not Applicable
-
(Transplant Eligible (TE) patients)
wblwlwipcl(rfrurmpyum) = pfpvqnfpff aaekwgzsnk (wllztpuost, -6.1 to -0.9)
-
09 Dec 2024
(Transplant Ineligible (TIE) patients)
wblwlwipcl(rfrurmpyum) = owzsteixdk aaekwgzsnk (wllztpuost, -7.6 to -2.1)
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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